Coronavirus COVID-19 Vaccines

William M. Detmer, MD, supported by the Unbound Medicine Team

Updated: January 13, 2021

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COVID-19 Vaccines in Late-Stage Development

Multiple vaccines are under development.
- Two have been approved for emergency use in several countries (Table 1).
- Ten have been under investigation in Phase 3 trials (Tables 1 and 2), 61 are in clinical trials (Table 3), and 172 in preclinical evaluation.[1]
For overview of trial design, see Clinical Trial Phases and Definitions
Among those with the greatest potential for speed are DNA- and RNA-based platforms, followed by those for developing recombinant-subunit vaccines.
RNA and DNA vaccines can be made quickly because they require no culture or fermentation, instead using synthetic processes.

Table 1. COVID-19 Vaccines Approved for Emergency Use or in Phase 3 Trials
Developer	# in Trial	Phase 3 Efficacy	Emergency Approval	#	Spacing (Days)	Vaccine Type	Storage Temp
Pfizer / BioNTech BNT162, Tozinameran	44k	95%[2]	UK: 2-Dec[3] CA: 9-Dec[4] US: 11-Dec[5] EU: 22-Dec[6]	2	21	mRNA	-70ºC
Moderna mRNA-1273	30k	94%[7]	US: 18-Dec[8] CA: 23-Dec[9] EU: 06-Jan[10] UK: 08-Jan[11]	2	28	mRNA	2–8ºC
AstraZeneca / Oxford AZD1222	24k	70%[12],[13]	UK: 30-Dec[14] AR: 30-Dec IN: 03-Jan MX: 04-Jan	2	28	Adenovirus	2–8ºC
Johnson & Johnson Ad26.COV2.S	60k			1	-	Adenovirus	2–8ºC
Novavax NVX-CoV2373	45k			2	21	Protein Subunit	2–8ºC
Sinovac CoronaVac	26k			2	14	Inactivated	2–8ºC
Sinopharm Inactivated virus, BBIBP-CorV	50k			2	21	Inactivated
Bharat Biotech BBV152	25k	Not yet reported	IN: 03-Jan	2	14	Inactivated
CanSino Biologics Ad5-nCoV	40k			1	-	Adenovirus	2–8ºC
Gamaleya Research Institute Gam-COVID-Vac (Sputnik V)	40k			2	21	Adenovirus	-18ºC
Trial = # of Phase 3 trial participants; Phase 3 Efficacy = Vaccine Efficacy/Effectiveness (reduction in disease among the vaccinated group); Emergency Approval = Date of Emergency Use Authorization (EUA); # = Number of Doses Required; US = United States; UK = United Kingdom; CA = Canada; EU = European Union; AR = Argentina; IN = India; MX = Mexico Recipient of U.S. Operation Warp Speed Funding

Recent News

RECENT UPDATES University of Oxford / AstraZeneca AZD1222 vaccine Vaccine approved for Emergency Use in the UK.[14] [December 30] Phase 3 trial interim results reported in the Lancet.[13] [December 8] Phase 3 trial interim results reported in a company press release showed reduction of COVID-19 infection by 70% in vaccine recipients.[12][15] Study enrolled more than 23,000 participants to date in the UK and Brazil and the first interim efficacy analysis was conducted when 131 COVID-19 cases were confirmed beginning two weeks after the second dose. One dosing regimen showed vaccine efficacy of 90% when AZD1222 was given as a half dose, followed by a full dose at least one month apart, and another dosing regimen showed 62% efficacy when given as two full doses at least one month apart (for a combined average efficacy of 70%). No hospitalizations for severe COVID-19 cases were reported in the group receiving a vaccine. Based on these results, the company intends to submit for an Emergency Use Authorization (EUA) with the World Health Organization in coming weeks. [November 23] Phase 3 trial resumed in the US after safety review by the FDA.[16] [October 23] Phase 3 trial resumed in the UK[17] (where the case of transverse myelitis occurred) but not yet in the United States, due to safety concerns at the NIH and FDA. [September 12] Phase 3 trial paused[18] due to a trial participant developing a serious neurological event, thought to be transverse myelitis[19]. Transverse myelitis is a rare disorder of the spinal cord that, like Guillain-Barré syndrome, can be triggered by certain viral infections, including SARS-CoV-2 itself. Investigators and the U.S. National Institutes of Health have pledged to fully investigate whether this case could be associated with the vaccine. [September 9] Preclinical study in rhesus macaques reported in Nature[20] showed that a single vaccination with ChAdOx1 nCoV-19 is effective in preventing damage to the lungs upon high dose challenge to both upper and lower respiratory tract with SARS-CoV-2; there was also no evidence of immune-enhanced disease in vaccinated animals. However, in regard to possible infectivity, nasal shedding of the virus was not significantly different between vaccinated and control animals. [July 30] Phase 1/2 trial published in Lancet[21] showed that in adults age 18–55 a single dose elicited both humoral and cellular responses against SARS-CoV-2, with a booster immunization augmenting neutralizing antibody titres. No serious adverse effect were reported; mild-moderate side effects were common. [July 20] Phase 3 trials that are underway in Brazil, South Africa, and the UK. Moderna mRNA-1273 vaccine Vaccine approved for Emergency Use in the US[5] [December 18], Canada[9] [December 23], EU[10] [January 6], and the UK[11] [January 8]. Phase 3 trial final results reported in a company press release showed vaccine efficacy of 94.1% against infection and 100% against severe COVID-19.[22] Results have not yet been published in a peer-reviewed journal. Final analysis performed after 196 COVID-19 were confirmed. Remarkably, 30 severe cases were observed — all in the placebo group and none in the vaccine group. Efficacy was consistent across age, race and ethnicity, and gender demographics. No serious side effects were observed. [November 30] Phase 3 study interim results reported in a company press release showed reduction of COVID-19 infection by 95% in vaccine recipients.[15] Results have not yet been published in a peer-reviewed journal. Study enrolled more than 30,000 participants to date and the first interim efficacy analysis was conducted when 95 COVID-19 cases were confirmed beginning two weeks after the second dose. Of these cases, 90 cases of COVID-19 were observed in the placebo group versus 5 in the vaccine group. Eleven severe cases were reported – all 11 cases occurred in the placebo group and none in the vaccine group. No serious side effects were reported. The trial is continuing to enroll and is expected to continue through the final analysis. [November 16] Results of Phase 1 clinical trial in older adults (56+ years of age) published in the New England Journal of Medicine[23] showed a robust antibody and cellular immune response in vaccinated individuals. Mild-moderate side effects were common but self-limited. [September 29] Preclinical study in non-human primates reported in New England Journal of Medicine.[24] Two injections elicited high levels of neutralizing antibody and Th1 CD4 T-cell responses in rhesus macaques. Two days after challenge of vaccinated animals with intranasal and intratracheal virus, viral replication was undetectable in bronchoalveolar-lavage fluid and nasal secretions. [July 28] Phase 1 study published in NEJM.[25] Forty-five adults age 18–55 were tested with one of three dose levels given as 2 vaccinations 28 days apart. All subjects produced antibodies and neutralizing activity on par with natural infection. Mild-moderate side effects were common. [July 14] BioNTech/Pfizer BNT162 vaccine Vaccine approved for Emergency Use in the UK[3] [December 2], Canada[4] [December 9], the U.S.[5] [December 11], and the EU.[6] [December 22] Phase 3 trial concluded showing reduction of COVID-19 infection by 95% in vaccine recipients.[26] In 43,661 participants, 170 confirmed cases of COVID-19 were evaluated, with 162 observed in the placebo group versus 8 in the vaccine group. [November 18] Phase 3 study interim results reported in a company press release showed reduction of COVID-19 infection by 90% in vaccine recipients.[27] Results have not yet been published in a peer-reviewed journal. Study enrolled 43,538 participants to date and the first interim efficacy analysis was conducted when 94 COVID-19 cases were confirmed. The case split between vaccinated individuals and those who received the placebo indicated a vaccine efficacy rate above 90%, at 7 days after the second dose (given at day 28). No serious side effects were reported. The trial is continuing to enroll and is expected to continue through the final analysis when a total of 164 confirmed COVID-19 cases have accrued. [November 9] Phase 1/2 trial published in Nature[28] showed that 60-person subset in immunized individuals generate a robust SARS-CoV-2-sepcific antibody and cellular mediated immune response which suggests multiple mechanisms with potential to protect against COVID-19. [September 30] Phase 1/2 trial results published in Nature[29] showing that in 36 healthy adults 18–55 who received 2 doses of vaccine separated by 21 days developed RBD-binding and neutralizing antibodies higher than with natural infection. Mild to moderate side effects were common. [August 12; preprint published July 1] U.S. government ordered 100 million doses of BNT162 for $1.95 billion as part of the U.S. Warp Speed program. A Phase 2b/3 safety and efficacy trial for the vaccine begins in late July 2020.[30][July 22] Johnson & Johnson/Janssen Ad26.COV2-S vaccine Trials resumed in the US after safety review by the company and an independent Data Safety Monitoring Board (DSMB) found no evidence that the vaccine candidate caused the medical event experienced by one study partipant.[31] [October 23] All trials of this vaccine paused (including Phase 3 trial)[32] due to an unexplained illness in a study participant. The company and a DSMB are investigating. [October 12] Phase 3 trial (ENSEMBLE) begun with 60,000 partipants from mulitple country.[33] [September 23] Preclinical study in rhesus macaques reported in Nature[34] showed a single dose of the adenovirus serotype 26 (Ad26) vector-based vaccine induced robust neutralizing antibody responses and provided complete or near-complete protection in bronchoalveolar lavage and nasal swabs following SARS-CoV-2 challenge. [July 30] Phase 1/2 trial began in late July. The company received Warp Speed funding of $456 million for pre-clinical and Phase 1 clinical trials. [March 30] INOVIO INO-4800 vaccine Phase 2/3 has been put on partial clinical hold until questions posed by the U.S. FDA about the candidate and the delivery device (CELLECTRA® 2000) have been satisfactorily addressed. This hold is not due to the occurrence of any adverse events. [September 28] Reports in a press release success of DNA-based vaccine INO-4800 in Phase 1 trial.[35][June 30] Novavax NVX-CoV2373 vaccine Phase 3 trial begins with 10k participants in the UK.[36] A similar trial is expected to start in the U.S in October. [September 24] Phase 1/2 trial published in New England Journal of Medicine[37] showed that in 106 healthy adults age 18–59 who received two doses spaced 21 days apart had robust immune responses with both IgG and neutralization antibodies 4-fold higher than seen in natural infection. Mild-moderate side effects were common and greater local and systemic reactogenicity occurred with the second dose. [September 2] Received U.S. Warp Speed funding for protein-based vaccine development and clinical trials.[38][July 7] Gamaleya Research Institute Gam-COVID-Vac vaccine Phase 1/2 trial results published in Lancet[39] showed 76 adults receiving one of two vaccine types (rAd26-S or rAd5-S) either alone or with a booster at 21 days generated both neutralizing and specific IgG antibodies. Mild-moderate side effects (pain at injection site, fever, headache, myalgia) were common, but no major side effects were reported. [September 4] Phase 1 trials of this vaccine were registered in June 2020 but no results have have been published in the scientific literature. Despite this, Russian President Vladimir Putin announced regulatory approval of the vaccine (to be called "Sputnik V" in foreign markets). Mass vaccination in Russia is expected to start in October 2020.[40][August 11] Sanofi/GSK protein subunit vaccine Phase 1/2 trial initiated with 400+ participants. [September 3] Sanofi reported it had secured an agreement with the U.S. government to provide 100 million doses of its experimental vaccine for up to $2.1 billion as part of Operation Warp Speed. [July 31] Wuhan Institute of Biological Products / Sinopharm β-propiolactone-inactivated-whole-virus vaccine Interim analysis of a Phase 1/2 trial reported in JAMA[41] showed that in 225 healthy adults aged 18–59 two injections of a medium dose spaced 21 days apart generated the most neutralizing and specific IgG antibodies and those levels were reported to be comparable to other vaccine candidates (but no direct comparisons was made to those vaccines or to convalescent plasma). Side effects were mild, self-limited and lower in frequency than what has been reported for other vaccine types. [August 13] BioNTech/Pfizer BNT162 vaccine Phase 1/2 trial results published in Nature[29] showing that in 36 healthy adults 18–55 who received 2 doses of vaccine separated by 21 days developed RBD-binding and neutralizing antibodies higher than with natural infection. Mild to moderate side effects were common. [August 12; preprint published July 1] U.S. government ordered 100 million doses of BNT162 for $1.95 billion as part of the U.S. Warp Speed program. A Phase 2b/3 safety and efficacy trial for the vaccine begins in late July 2020.[30][July 22] CanSino Biologics Adenovirus Type 5 vectored vaccine Phase 2 trial published in Lancet[42] showed that in 382 adults age ≥ 18 a single dose induced cellular or humoral immune responses at day 28 post vaccination in 91–95% of recipients depending on the dose. Mild-moderate side effects were common; Grade 3 adverse effects were seen in 9%. [July 20] Received Military Specially-needed Drug Approval (軍隊特需藥品批件) for non-replicating adenovirus vaccine Ad5-nCoV for use in the Chinese military.[43][June 25] INOVIO reports in a press release success of DNA-based vaccine INO-4800 in Phase 1 trial.[35][June 30]

Table 2. COVID-19 Candidate Vaccines in Phase 3 Trials
Developer	Phase 1*	Phase II	Phase III
Pfizer / BioNTech/ BNT162	NCT04368728 Results in NEJM[44]	NCT04537949 Results in Nature[29]	NCT04537949 Positive final results.[27],[26]
Moderna/ NIAID mRNA-1273	NCT04283461 Results in NEJM[25],[23]	NCT04405076	NCT04470427 Positive final results.[15],[22]
University of Oxford/ AstraZeneca AZD1222	NCT04324606 Results in Lancet[45]		NCT04516746 Positive interim results.[12]
Sinovac CoronaVac	NCT04383574 NCT04352608 Results in Science[46]		NCT04456595
Wuhan Institute of Biological Products/ Sinopharm Inactivated virus	ChiCTR-2000031809 Results in JAMA[41]		ChiCTR-2000034780
Beijing Institute of Biological Products/ Sinopharm BBIBP-CorV	ChiCTR-2000032459 Results in Lancet Infect Dis[47]		ChiCTR-2000034780
Bharat Biotech BBV152	CTRI/2020/07/026300		CTRI-2020/11/028976
CanSino Biological Inc/ Beijing Institute of Biotechnology Ad5-nCoV	NCT04313127 Results in Lancet[48]	NCT04341389 Results in Lancet[42]	NCT04526990; NCT04540419
Gamaleya Research Institute Gam-COVID-Vac, Sputnik V	NCT04437875; Results in Lancet[39]	NCT04587219	NCT04530396
Janssen Pharmaceutical Companies Ad26.COV2.S	NCT04436276		NCT04505722
Novavax NVX-CoV2373	NCT04368988 Results in NEJM[37]		2020-004123-16
*Trials spanning Phase 1 and 2 represent Phase 1/2 trials.

COVID-19 Vaccines in Clinical Trials

Table 2. COVID-19 Candidate Vaccines Undergoing Clinical Evaluation^†
Developer	Platform	Type	Current stage
Moderna/ NIAID	RNA	LNP-encapsulated mRNA (mRNA-1273)	Phase 3 NCT04470427; Positive final results.[15],[22] Phase 2 NCT04405076 Phase 1 NCT04283461; Results in NEJM[25],[23]
BioNTech/ Fosun Pharma/ Pfizer	RNA	3 LNP-mRNAs (BNT162)	Phase 3 NCT04368728; Positive final results.[27],[26] Phase 1/2 NCT04537949; Results in Nature[29]
University of Oxford/ AstraZeneca	Non-Replicating Viral Vector	Weakened adenovirus (ChAdOx1-S; AZD1222)	Phase 3 NCT04516746; Positive interim results.[12] Phase2b/3 NCT04400838 Phase 1/2 PACTR202006922165132; 2020-001072-15; Results in Lancet[48]
Sinovac	Inactivated	Inactivated + alum (CoronaVac; formerly PiCoVacc)	Phase 3 NCT04456595 Phase 1/2 NCT04383574 ; NCT04352608; Results in Science[46]
Wuhan Institute of Biological Products/ Sinopharm	Inactivated	Inactivated	Phase 3 ChiCTR2000034780 Phase 1/2 ChiCTR2000031809; Results in JAMA[41]
Beijing Institute of Biological Products/ Sinopharm	Inactivated	Inactivated (BBIBP-CorV)	Phase 3 ChiCTR2000034780 Phase 1/2 ChiCTR2000032459
CanSino Biological Inc./ Beijing Institute of Biotechnology	Non-Replicating Viral Vector	Adenovirus Type 5 Vector (Ad5-nCoV)	Phase 3 NCT04526990; NCT04540419 Phase 2 NCT04341389; Results in Lancet[42] Phase 1 NCT04313127; Results in Lancet[48]
Gamaleya Research Institute	Non-Replicating Viral Vector	Adenovirus-based (Gam-COVID-Vac; Гам-КОВИД-Вак)	Phase 3 NCT04530396 Phase 1 NCT04436471; NCT04437875; Results in Lancet[39]
Anhui Zhifei Longcom Biopharmaceutical/ Institute of Microbiology, Chinese Academy of Sciences	Protein Subunit	Adjuvanted recombinant protein (RBD-Dimer)	Phase 2 NCT04466085 Phase 1 NCT04445194
Inovio Pharmaceuticals / International Vaccine Institute	DNA	DNA plasmid vaccine with electroporation (INO-4800)	Phase 1/2 NCT04336410; NCT04447781
Novavax	Protein Subunit	Recombinant SARS CoV-2 glycoprotein nanoparticle vaccine adjuvanted with Matrix M (NVX-CoV2373)	Phase 3 2020-004123-16 Phase 2b NCT04533399 Phase 1/2 NCT04368988; Results in NEJM[37]
Janssen Pharmaceutical Companies	Non-Replicating Viral Vector	Ad26.COV2.S	Phase 3 NCT04505722 Phase 1/2 NCT04436276
Bharat Biotech	Inactivated	Whole-Virion Inactivated	Phase 1/2 CTRI/2020/07/026300
Kentucky Bioprocessing, Inc	Protein Subunit	RBD-based	Phase 1/2 NCT04473690
Institute of Medical Biology, Chinese Academy of Medical Sciences	Inactivated	Inactivated	Phase 1/2 NCT04470609 Phase 1 NCT04412538
Sanofi Pasteur/GSK	Protein Subunit	S protein (baculovirus production	Phase 1/2 NCT04537208
Research Institute for Biological Safety Problems, Rep of Kazakhstan	Inactivated	Inactivated	Phase 1/2 NCT04530357
SpyBiotech/Serum Institute of India	VLP	RBD-HBsAg VLPs	Phase 1/2 ACTRN12620000817943
Genexine Consortium	DNA	DNA Vaccine (GX-19)	Phase 1 NCT04445389
Cadila Healthcare Limited	DNA	DNA plasmid vaccine	Phase 1/2 CTRI/2020/07/026352
Osaka University/ AnGes/ Takara Bio	DNA	DNA plasmid vaccine + Adjuvant	Phase 1 JapicCTI-205328
Gamaleya Research Institute	Non-Replicating Viral Vector	Adenovirus-based (Gam-COVID-Vac; Гам-КОВИД-Вак)	Phase 1 NCT04436471; NCT04437875
Clover Biopharmaceuticals Inc./ GSK/ Dynavax	Protein Subunit	Native like Trimeric subunit Spike Protein vaccine (SCB-2019)	Phase 1 NCT04437875
Arcturus/Duke-NUS	RNA	mRNA	Phase 1/2 NCT04480957
Vaxine Pty Ltd/ Medytox	Protein Subunit	Recombinant spike protein with Advax™ adjuvant	Phase 1 NCT04453852
University of Queensland/ CSL/ Seqirus	Protein Subunit	Molecular clamp stabilized Spike protein with MF59 adjuvant	Phase 1 ACTRN12620000674932p
Imperial College London	RNA	LNP-nCoVsaRNA	Phase 1 ISRCTN17072692
Curevac	RNA	mRNA	Phase 1 NCT04449276
Medigen Vaccine Biologics Corporation/ NIAID/ Dynavax	Protein Subunit	S-2P protein + CpG 1018	Phase 1 NCT04487210
People’s Liberation Army (PLA) Academy of Military Sciences/Walvax Biotech	RNA	mRNA	Phase 1 ChiCTR2000034112
Medicago Inc./ Université Laval	VLP	Plant-derived VLP	Phase 1 NCT04450004
Institute Pasteur/ Themis/ Univ. of Pittsburg CVR/ Merck Sharp & Dohme	Replicating Viral Vector	Measles-vector based	Phase 1 NCT04497298
ReiThera/ LEUKOCARE/ Univercells	Non-Replicating Viral Vector	Replication defective Simian Adenovirus (GRAd) encoding S	Phase 1 NCT04528641
Instituto Finlay de Vacunas, Cuba	Protein Subunit	RBD + Adjuvant	Phase 1 IFV/COR/04
FBRI SRC VB VECTOR, Rospotrebnadzor, Koltsovo	Protein Subunit	Peptide	Phase 1 NCT04527575
West China Hospital, Sichuan University	Protein Subunit	RBD (baculovirus production expressed in Sf9 cells)	Phase 1 ChiCTR2000037518
University Hospital Tuebingen	Protein Subunit	SARS-CoV-2 HLA-DR peptides	Phase 1 NCT04546841
COVAXX	Protein Subunit	S1-RBD-protein	Phase 1 NCT04497298
Beijing Wantai Biological Pharmacy/ Xiamen University	Replicating Viral Vector	Intranasal flu-based-RBD	Phase 1 ChiCTR2000037782
Vaxart	Non-Replicating Viral Vector	Ad5 adjuvanted Oral Vaccine platform	Phase 1 NCT04563702
Ludwig-Maximilians - University of Munich	Non-Replicating Viral Vector	MVA-SARS-2-S	Phase 1 NCT04569383
^†Adapted from Draft landscape of COVID-19 candidate vaccines. WHO. 22 December 2020.[1] LNP = lipid nanoparticle; RBD = receptor-binding domain; mRNA = messenger RNA; VLP = virus-like particles Recipient of U.S. Operation Warp Speed Funding[49],[50]

COVID-19 Vaccine Trial Phases and Definitions

Preclinical Testing

In a Preclinical trial, the vaccine is given to animals such as mice or monkeys, typically rhesus macaques (Macaca mulatta), to see if it produces an immune response.

Phase 1

In a Phase I trial, the vaccine candidate is given to a small number of people to test safety and dosage as well as to confirm that it stimulates the immune system.

Phase 2

In a Phase II trial, the vaccine candidate is given to hundreds of people split into different age or risk groups groups to see if the vaccine acts differently in different populations. These trials further test the vaccine’s safety and ability to stimulate the immune system.

Phase 3

In a Phase III trial, the vaccine candidate is given to thousands of people and wait to see how many become infected, compared with those who received a placebo. These trials can determine if the vaccine protects against the coronavirus.

Approval

Regulators in each country review the trial results and decide whether to approve the vaccine or not. During a public health emergency, a vaccine may receive Emergency Use Authorization (EUA) before getting formal approval.

Phase 4

In a Phase IV trial – also known as a postmarketing surveillance trial or a confirmatory trial – the vaccine is monitored for safety, side effects and efficacy after it has been approved and made available to the public.

Warp Speed

The U.S. government’s Operation Warp Speed program is expected to name five or more vaccine projects to receive billions of dollars in federal funding before there’s proof that the vaccines work.

Combined Phases

Some coronavirus vaccines are now in combined phase trials to speed evalutation. For instance, many Phase 1/2 trials are underway to test a vaccine for the first time on hundreds of people.

COVID-19 ClinicalTrials.gov Trials

COVID-19 vaccine clinical trials from ClinicalTrials.gov

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References

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Last updated: January 13, 2021